Clene Secures $28M Oversubscribed Financing, Eyes NDA Filing by June
Clene secured an oversubscribed $28 million registered direct offering with a $6 million initial tranche providing cash runway to Q3 2026. The company expects an FDA Type C meeting by end of Q1 2026, written minutes in Q2, and aims to file an NDA for CNM-Au8 in ALS by end of June 2026.
1. FDA Meeting and NDA Timeline
Clene has scheduled an in-person Type C meeting with the FDA by the end of Q1 2026 to discuss CNM-Au8 biomarker and survival data, with formal written minutes expected early in Q2. The company plans to file an accelerated approval NDA for CNM-Au8 in ALS by the end of June 2026.
2. Oversubscribed Financing Secured
In January 2026, Clene completed an oversubscribed registered direct offering raising over $28 million, including a $6 million initial tranche priced above market. The proceeds will fund operations through Q3 2026, with two additional tranches tied to NDA acceptance and FDA approval milestones to extend the runway into 2027.
3. 2025 Financial Highlights
As of December 31, 2025, Clene held $5.2 million in cash and equivalents versus $12.2 million a year earlier. Research and development expenses declined to $14.0 million from $20.1 million, general and administrative expenses fell to $9.2 million from $13.3 million, and other expenses dropped to $3.1 million from $6.3 million.
4. CNM-Au8 Biomarker and Safety Data
December 2025 analyses showed statistically significant reductions in neurofilament light chain and glial fibrillary acidic protein linked to improved survival in ALS patients. Over 1,100 patient-years of exposure revealed no serious adverse events related to CNM-Au8, supporting plans for confirmatory Phase 3 trials in ALS and a cognition-based Phase 3 study in MS.